510(k) K160120 ยท KPS System, Tomography, Computed, Emission
D-SPECT Processing and Reviewing Workstation
| Applicant | Spectrum Dynamics , Ltd., Caesarea, IL |
| Decision | Substantially Equivalent, Mar 21, 2016 |
| Received | Jan 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160120
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.